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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00615238 |
Purpose
Although exercise is widely regarded as a key component in obesity treatment, few individuals seem able to adhere to exercise programs over time. In response, efforts have focused on developing new approaches to physical activity that may appeal to sedentary overweight persons. For instance, is has been shown that accumulating multiple short bouts of vigorous exercise may enhance both exercise adherence and weight loss in overweight persons. Accumulating moderate-intensity activity throughout the day may offer comparable health and weight benefits as a traditional exercise program. Public health recommendations now include the option of accumulating 30 minutes of moderate-intensity lifestyle activity for health and well-being. While these two options offer a viable alternative to those who dislike or cannot sustain continuous vigorous exercise programs, it is unclear whether the flexibility of accumulating physical activity or the vigorous intensity of the exercise is responsible for improved weight loss and long-term adherence.
The goal of this research is to extend our preliminary findings suggesting that moderate intensity lifestyle activity is an important and viable alternative to traditional structured vigorous exercise for obese dieting individuals. The primary specific aim of this project is to compare the effects of three modes of exercise on long-term weight regain. Participants will be 165 overweight men and women who are sedentary, but otherwise healthy. All participants will receive the same 16-week behavioral weight loss program and will be randomized to one of three exercise study conditions: 1) diet-plus-continuous bouts of vigorous aerobic exercise; 2) diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day; or 3) diet-plus-moderate intensity lifestyle activity accumulated throughout the day. By varying both the intensity and duration of exercise bouts, we can determine which type of exercise is associated with optimal outcomes one year later. Additional questions of interest include:
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: diet-plus-continuous bouts of vigorous aerobic exercise Behavioral: diet plus shorts bouts Behavioral: diet plus lifestyle activity |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Physical Activity in the Treatment of Obesity: A Randomized Trial |
| Enrollment: | 177 |
| Study Start Date: | April 2000 |
| Study Completion Date: | May 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
diet-plus-continuous bouts of vigorous aerobic exercise
|
Behavioral: diet-plus-continuous bouts of vigorous aerobic exercise
Patients consumed a 1200 kcal/d diet and were instructed to perform 4 30-60 minute aerobic workouts per week
|
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2: Experimental
diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day
|
Behavioral: diet plus shorts bouts
Patients consumed a 1200 kcal/d diet and were instructed to perform short 10 minutes bouts of aerobic exercise 4 times per week
|
|
3: Experimental
diet-plus-moderate intensity lifestyle activity accumulated throughout the day
|
Behavioral: diet plus lifestyle activity
Patients consumed a 1200 kcal/d diet and were instructed to accumulate moderate intensity physical activity on most days of the week.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:Sedentary and >30 pounds above healthy weight. No plans to move from area for next 1.5 years. No plans for excessive travel.
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Exclusion Criteria: recent weight loss or regular exercise (≥2 bouts per week), serious medical or psychiatric condition (cardiovascular, metabolic or orthopedic) or history of clinical depression or eating disorder.
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Contacts and Locations| United States, Maryland | |
| Johns Hopkins School of Medicine | |
| Baltimore, Maryland, United States, 21224 | |
| Study Director: | Jeremey D Walston, MD | JHU School of Med |
| Study Director: | Susan J Bartlett, PhD | JHU School of Med |
More Information
| Responsible Party: | McGill University ( Ross E. Andersen, Ph.D. / Professor ) |
| Study ID Numbers: | DK53907, RO1 DK 53907-01A1 |
| Study First Received: | February 12, 2008 |
| Last Updated: | February 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00615238 |
| Health Authority: | United States: Federal Government |
|
overweight, physical activity, body composition, metabolic syndrome |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
